CSV Validation Manager – R&D IT Systems

Ipsen Group; Paris; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A leading biopharmaceutical company in Paris is seeking a Validation CSV Expert to ensure compliance and quality in R&D IT systems. This role involves defining CSV strategies, managing the full validation lifecycle, and collaborating cross-functionally to maintain audit readiness. The ideal candidate has 6-8 years of experience in CSV within the pharma industry, knowledge of regulatory frameworks, and strong stakeholder management skills. The role is pivotal in balancing innovation and compliance, contributing significantly to patient impact.

Qualifications

• 6–8 years of experience in Computer System Validation (CSV) within the pharmaceutical or life sciences industry.
• Strong knowledge of regulatory frameworks such as GxP and FDA 21 CFR Part 11.
• Solid experience managing the validation lifecycle and audit/inspection processes.

Responsabilités

• Define and lead the CSV strategy for R&D IT systems.
• Act as the guarantor of system validation and compliance.
• Oversee the full validation lifecycle and manage change control processes.

Connaissances

Computer System Validation (CSV)

Regulatory frameworks knowledge

Stakeholder management

Audit and inspection management

Fluent in English

Outils

Veeva

LIMS

ELN

Description du poste

A leading biopharmaceutical company in Paris is seeking a Validation CSV Expert to ensure compliance and quality in R&D IT systems. This role involves defining CSV strategies, managing the full validation lifecycle, and collaborating cross-functionally to maintain audit readiness. The ideal candidate has 6-8 years of experience in CSV within the pharma industry, knowledge of regulatory frameworks, and strong stakeholder management skills. The role is pivotal in balancing innovation and compliance, contributing significantly to patient impact.